The Efficacy of Pressurised Intraperitoneal Aerosol Chemotherapy (PIPAC) Combined With CURativE Intent Minimally Invasive Radical Resection in High-risk Gastric Cancer Patients. A Multicentre, Randomised, Open-label Phase-II Study
Odense University Hospital
Summary
The goal of this randomized clinical trial is to investigate whether pressurized intraperitoneal chemotherapy (PIPAC), delivered immediately after minimally invasive D2 gastrectomy and repeated 6-8 weeks later, improves 12-month peritoneal disease-free survival in patients with high-risk gastric adenocarcinoma when compared to standard treatment.
Description
Despite declining incidence, gastric adenocarcinoma (GAC) is considered the fifth most common cancer worldwide and the third leading cause of cancer death globally. Its incidence varies across different parts of the globe, with a low incidence in the West. In East Asia, especially Japan and Korea, the incidence of distal GAC remains high, whereas proximal GAC tends to dominate in the West. Gastroesophageal junction (GEJ) adenocarcinomas that have the epicentre in the proximal 2 to 5 cm of the stomach (Siewert type III) should be staged and treated as GAC. The consensus in most Western countri…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion criteria * Gastric or Gastroesophageal junction Siewert type III adenocarcinomas * Clinical T3-4a-stages 1. Any differentiation grade 2. Any histological subtype * Clinical T2-stage a. If poorly differentiated or of the poorly cohesive histological subtype, with or without the presence of signet-ring cells * Any clinical T-stage with positivity for malignant cells on abdominal lavage cytology, which is converted to cytology negative in response to neoadjuvant chemotherapy. * Any clinical nodal-stage * clinical M0-stage (positive abdominal wash cytology, which is converted to…
Interventions
- DrugCisplatin
10.5 mg/m2 body surface in 150ml saline
- DrugDoxorubicin
2.1 mg/m2 body surface in 50ml saline
Locations (5)
- City of HopeDuarte, California
- Odense University HospitalOdense C
- University Hospital LilleLille
- Charité, University of BerlinBerlin
- Karolinska University HospitalStockholm